Exo Checker
A practical orientation tool based on ASTM and FDA definitions
A practical orientation tool based on ASTM and FDA definitions
ASTM F3323 Definition: An exoskeleton is a wearable device that augments, enables, assists, and/or enhances physical activity through mechanical interaction with the body.
FDA Regulation (21 CFR 890.3480): A powered exoskeleton is a prescription device composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes. It facilitates movement of one or multiple lower extremity joints (e.g., hip, knee, ankle).
Enter a description of the device. The tool checks alignment with the ASTM F3323 and FDA definitions above. This is an orientation aid, not a formal determination or regulatory opinion.
If the analysis raises questions or you want to discuss standards, definitions, or related topics, a selective conversation is available by request.